Rotational atherectomy device with exchangeable drive shaft and meshing gears

ABSTRACT

An atherectomy device with an exchangeable drive shaft is disclosed, having a drive shaft gear at a distal end of the exchangeable drive shaft for meshing engagement with a prime mover gear on the output shaft of the prime mover. The exchangeable drive shaft is inserted into an opening at the distal end of the handle housing and moved axially in a proximal direction. Surface features on at least the prime mover housing and the engageable drive shaft help to align the drive shaft gear with the prime mover gear for meshing engagement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/340,353 filed Jul. 24, 2014 which claims the benefit of U.S.Provisional Application No. 61/950,402, filed Mar. 10, 2014, and thebenefit of U.S. Provisional Application No. 61/858,345 filed Jul. 25,2013, the entirety of which prior filed applications are herebyincorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The disclosure relates to devices and methods for removing tissue frombody passageways, such as removal of atherosclerotic plaque fromarteries, utilizing a rotational atherectomy device. In particular, thedisclosure relates to improvements in a rotational atherectomy devicehaving an exchangeable drive shaft.

2. Description of the Related Art

A variety of techniques and instruments have been developed for use inthe removal or repair of tissue in arteries and similar bodypassageways. A frequent objective of such techniques and instruments isthe removal of atherosclerotic plaque in a patient's arteries.Atherosclerosis is characterized by the buildup of fatty deposits(atheromas) in the intimal layer (i.e., under the endothelium) of apatient's blood vessels. Very often over time what initially isdeposited as relatively soft, cholesterol-rich atheromatous materialhardens into a calcified atherosclerotic plaque. Such atheromas restrictthe flow of blood, and therefore often are referred to as stenoticlesions or stenoses, the blocking material being referred to as stenoticmaterial. If left untreated, such stenoses can cause angina,hypertension, myocardial infarction, strokes and the like.

Several kinds of atherectomy devices have been developed for attemptingto remove some or all of such stenotic material. In one type of device,such as that shown in U.S. Pat. No. 4,990,134 (Auth), a rotating burrcovered with an abrasive cutting material, such as diamond grit (diamondparticles or dust), is carried at the distal end of a flexible,rotatable drive shaft.

U.S. Pat. No. 5,314,438 (Shturman) shows another atherectomy devicehaving a rotatable drive shaft with a section of the drive shaft havingan enlarged diameter, at least a segment of this enlarged diametersection being covered with an abrasive material to define an abrasivesegment of the drive shaft. When rotated at high speeds, the abrasivesegment is capable of removing stenotic tissue from an artery.

U.S. Pat. No. 5,314,407 (Auth) shows details of a type of handle whichmay be used in conjunction with rotational atherectomy devices of thetype shown in the Auth '134 and Shturman '438 patents. A handle of thetype shown in the Auth '407 patent has been commercialized by HeartTechnology, Inc. (Redmond, Wash.), now owned by Boston ScientificCorporation (Natick, Mass.) in the rotational atherectomy device soldunder the trademark Rotablator®. The handle of the Rotablator® deviceincludes a variety of components, including a compressed gas driventurbine, a mechanism for clamping a guide wire extending through thedrive shaft, portions of a fiber optic tachometer, and a pump forpumping saline through the drive shaft.

The connection between the drive shaft (with its associated burr) andthe turbine in the Rotablator® device is permanent; yet, frequently itis necessary to use more than one size burr during an atherectomyprocedure. That is, often a smaller size burr is first used to open astenosis to a certain diameter, and then one or more larger size burrsare used to open the stenosis further. Such use of multiple burrs ofsubsequently larger diameter is sometimes referred to as a “step uptechnique” and is recommended by the manufacturer of the Rotablator®device. In the multiple burr technique it is necessary to use a newRotablator® device for each such successive size burr. Accordingly,there is a need for an atherectomy system that would permit a physicianto use only one handle throughout an entire procedure and to attach tosuch handle an appropriate drive shaft and tissue removing implement(e.g., a burr) to initiate the procedure and then exchange the driveshaft and the tissue removing implement for a drive shaft having atissue removing implement of a different size or even a differentdesign.

A subsequent version of the Rotablator® has been introduced with theability to exchange a flexible distal portion of the drive shafttogether with a burr for another distal portion of a drive shaft havinga different size burr. Technical details of such a system are containedin U.S. Pat. No. 5,766,190, titled “Connectable driveshaft system”, andissued on Jun. 16, 1998 to Wulfman. This system utilizes a flexibledrive shaft having a connect/disconnect feature allowing the physicianto disconnect the exchangeable distal portion of the flexible driveshaft together with the burr from the flexible proximal portion of thedrive shaft which is connected to the turbine of the handle, thuspermitting the burr size to be changed without discarding the entireatherectomy unit. Each exchangeable drive shaft portion is disposedwithin its own exchangeable catheter and catheter housing. The flexibleproximal portion of the drive shaft in this system is permanentlyattached to the turbine and is not exchanged. This system has beencommercialized by Boston Scientific under the trademark RotalinkSystem®. While the Rotalink System® does permit one to change the burrsize, the steps required to actually disconnect the exchangeable portionof the drive shaft and replace it with another exchangeable portion ofthe drive shaft are quite involved and require relatively intricatemanipulation of very small components.

First, a catheter housing must be disconnected from the handle and moveddistally away from the handle to expose portions of both the proximaland distal sections of the flexible drive shaft which contain adisconnectable coupling. This coupling is disconnected by sliding a locktube distally, permitting complementary lock teeth on the proximal anddistal portions of the flexible drive shaft to be disengaged from eachother. A similar flexible distal drive shaft portion with a differentburr may then be connected to the flexible proximal portion of the driveshaft. To accomplish such assembly, the lock tooth on the proximal endof the distal replacement portion of the drive shaft must first be bothlongitudinally and rotationally aligned with the complementary locktooth at the distal end of the proximal portion of the drive shaft.Since the flexible drive shaft typically is less than 1 mm in diameter,the lock teeth are similarly quite small in size, requiring notinsignificant manual dexterity and visual acuity to properly align andinterlock the lock teeth. Once the lock teeth have been properlyinterlocked with each other, the lock tube (also having a very smalldiameter) is slid proximally to secure the coupling. The catheterhousing must then be connected to the handle housing.

While this system does permit one to exchange one size burr (togetherwith a portion of the drive shaft) for a burr of another size, theexchange procedure is not an easy one and must be performed withconsiderable care. The individual performing the exchange procedure mustdo so while wearing surgical gloves to protect the individual from theblood of the patient and to maintain the sterility of the elements ofthe system. Surgical gloves diminish the tactile sensations of theindividual performing the exchange procedure and therefore make suchexchange procedure even more difficult.

In recent years, there has been an effort to develop an atherectomydevice with easier attachment and/or exchange of the drive shaft and itstissue removing implement.

For instance, U.S. Pat. No. 6,024,749 (Shturman et al), U.S. Pat. No.6,077,282 (Shturman et al), U.S. Pat. No. 6,129,734 (Shturman et al) andU.S. Pat. No. 6,852,118 (Shturman et al), all incorporated by referencein their entirety herein, disclose an atherectomy device having anexchangeable drive shaft cartridge comprising a housing that isremovably attachable to the device's handle housing. The exchangeablecartridge includes a longitudinally movable tube that is removablyattached to the prime mover carriage and a rotatable drive shaft that isremovably attachable to the prime mover. A coupling is provided whichconnects the longitudinally extendible tube to the prime mover whileindexing the relative position of the longitudinally extendible tube andthe proximal portion of the drive shaft. U.S. Patent Publication No.2011/0087254 (Welty), incorporated by reference in its entirety herein,discloses an atherectomy device where the prime mover has a prime movercoupler and the drive shaft has a drive shaft coupler that is engageablewith the prime mover coupler. The drive shaft coupler and prime movercoupler have engageable lateral cross-sections that are complementaryand geometrically keyed to one another. When they are engaged to oneanother, the complementary cross-sections allow axial translationbetween the drive shaft coupler and the prime mover coupler whileprohibiting rotational coupler between the drive shaft coupler and theprime mover coupler.

Other atherectomy devices, such as U.S. Patent Pub. No. 2011/0077673(Grubac et al), utilize a magnetic clutch connection between the driveshaft and the prime mover. The drive shaft and the prime mover are heldtogether longitudinally by a magnetic attractive force between the motorplate and the drive shaft plate. The torques between the motor and thedrive shaft are transmitted completely between the motor plate and thedrive shaft plate and, when below a threshold torque, the motor plateand the drive shaft plate remain held together rotationally by staticfriction. When the torques between the motor and the drive shaft aregreater than the threshold torque, the motor plate and the drive shaftplate slip rotationally past each other, causing a residual torque to betransmitted between the motor and the drive shaft.

Although the above devices utilize friction or magnetic couplings toremovably engage the drive shaft with the prime mover, some atherectomydevices have a driveshaft driven by a pair of mating gears, one gearconnected to the drive shaft and one gear connected to the mating gear.Due to this gearing arrangement, the atherectomy device is generallyrestricted to one shaft size per assembly. Typically the gear connectedto the drive shaft is not replaced, so any exchangeable drive shaft mustbe sized to properly engage with the drive shaft. Thus, multipleatherectomy devices are needed for each desired drive shaft diameter.

Accordingly, there exists a need for an atherectomy device with themating gear assembly where the drive shaft is exchangeable for anotherdrive shaft of either the same size or another size.

BRIEF SUMMARY OF THE INVENTION

An embodiment of a rotational atherectomy device includes a handlehaving a proximal section, a distal section having a channel extendingproximally from an opening in a distal end of the handle, and anelongated hollow intermediate section between the proximal and thedistal sections. The intermediate section includes an opening between aninterior thereof and the channel in the distal section, and a slot. Thedevice further includes a prime mover carriage having a prime mover, anda prime mover gear fixedly attached to a shaft of the prime mover. Theprime mover carriage is disposed within the interior of the intermediatesection. The device further includes a control knob having at least aportion thereof extending through the slot in the intermediate sectionand operationally coupled to the prime mover carriage such that alongitudinal displacement of the control knob induces a longitudinaldisplacement of the prime mover carriage. The control knob is operableto an unlocked state for permitting the longitudinal displacement of thecontrol knob, and to a locked state for inhibiting the longitudinaldisplacement of the control knob. Some embodiments of the device includean exchangeable drive shaft cartridge having a proximal section and adistal section, and a drive shaft having a proximal end and a distalend. The drive shaft extends through an opening in the distal section ofthe drive shaft cartridge. The drive shaft cartridge includes a gearengagement assembly having a drive shaft gear fixedly attached to theproximal end of the drive shaft. Some embodiments of the device includeone or more connectors for removably connecting the distal section ofthe handle and the distal section of the drive shaft cartridge to oneanother. Certain embodiments of the one or more connectors includescomplementary first and second sections, wherein the first section ofeach connector is integrally formed with the distal section of handle,and the complementary second section of each connector is integrallyformed with the distal section of the drive shaft cartridge. The deviceincludes at least one alignment element on at least one of the gearengagement assembly, the prime mover carriage and the interior of theintermediate section of the handle. The at least one alignment elementis configured for aligning at least the prime mover gear and the driveshaft gear with one another when the gear engagement assembly isextended into the interior of the intermediate section and positionedproximate the prime mover. The device further includes at least onebiasing element configured for removably meshing the prime mover gearand the drive shaft gear when the prime mover gear and the drive shaftgear are aligned with one another such that a rotational movement of oneof the prime mover and the drive shaft induces a rotational movement inthe other.

Another embodiment of a rotational atherectomy device includes a handlehaving a proximal section, a distal section having a channel extendingproximally from an opening in a distal end of the handle, and anelongated intermediate section having a trough extending between theproximal and the distal sections. The device further includes a primemover carriage having a prime mover, and a prime mover gear fixedlyattached to a shaft of the prime mover. The prime mover carriagedisposed within the trough of the intermediate section. Some embodimentsof the device include an exchangeable drive shaft cartridge having aproximal section and a distal section, a slot in an intermediate sectionextending between the proximal and the distal sections, a drive shafthaving a proximal end and a distal end. The drive shaft extends throughan opening in the distal section of the drive shaft cartridge. The driveshaft cartridge includes a gear engagement assembly having a drive shaftgear fixedly attached to the proximal end of the drive shaft, and acontrol knob having at least a portion thereof extending through theslot and operationally coupled to the drive shaft cartridge such that alongitudinal displacement of the control knob induces a longitudinaldisplacement of the drive shaft cartridge. The control knob can beoperated to an unlocked state for permitting the longitudinaldisplacement of the control knob, and to a locked state for inhibitingthe longitudinal displacement of the control knob. Certain embodimentsof the device include one or more connectors for removably connectingthe handle and the drive shaft cartridge to one another. Someembodiments of the one or more connectors include complementary firstand second sections, wherein the first section is integrally formed withthe handle, and the complementary second section is integrally formedwith the drive shaft cartridge. The handle and the drive shaft cartridgeare removably connected by removably meshing the prime mover gear andthe drive shaft gear by juxtaposing the prime mover carriage and thegear engagement assembly, and concurrently displacing the handle and thedrive shaft cartridge in opposite directions.

Yet another embodiment of a rotational atherectomy device includes ahandle having a proximal section, a distal section having a trough, andan elongated hollow intermediate section between the proximal and thedistal sections. The intermediate section includes an opening between aninterior thereof and the trough, and a slot. The device further includesa prime mover carriage having a prime mover and a prime mover gearfixedly attached to a shaft of the prime mover. In some embodiments, theprime mover carriage is disposed within the interior of the intermediatesection. Some embodiments of the device include a control knob having atleast a portion thereof extending through the slot and operationallycoupled to the prime mover carriage such that a longitudinaldisplacement of the control knob induces a longitudinal displacement ofthe prime mover carriage. The control knob can be operated to anunlocked state for permitting the longitudinal displacement of thecontrol knob, and to a locked state for inhibiting the longitudinaldisplacement of the control knob. The device further includes anexchangeable drive shaft cartridge having a proximal section and adistal section, and a drive shaft having a proximal end and a distalend. The drive shaft extends through an opening in the distal section ofthe drive shaft cartridge. The drive shaft cartridge includes a gearengagement assembly having a drive shaft gear fixedly attached to theproximal end of the drive shaft, and one or more connectors forremovably connecting the handle and the drive shaft cartridge to oneanother, wherein each of the one or more connectors includescomplementary first and second sections, wherein the first section isintegrally formed with the handle and the complementary second sectionis integrally formed with the drive shaft cartridge. The handle and thedrive shaft cartridge are removably connected by inserting at least thegear engagement assembly through the opening in the intermediate sectionof the handle, removably meshing the prime mover gear and the driveshaft gear by juxtaposing the prime mover carriage and the gearengagement assembly, and displacing the handle and the drive shaftcartridge in opposite directions.

Another embodiment of a rotational atherectomy device includes a handlehaving a proximal section, a distal section, and an elongated hollowintermediate section between the proximal and the distal sections. Theintermediate section includes a door for accessing an interior thereof,an opening between the interior and the distal section, and a slot. Thedevice further includes a prime mover carriage having a prime mover, anda prime mover gear fixedly attached to a shaft of the prime mover. Incertain embodiments, the prime mover carriage is disposed within theinterior of the intermediate section. Some embodiments of the deviceinclude a control knob having at least a portion thereof extendingthrough the slot and operationally coupled to the prime mover carriagesuch that a longitudinal displacement of the control knob induces alongitudinal displacement of the prime mover carriage. Certainembodiments of the control knob can be operated to an unlocked state forpermitting the longitudinal displacement of the control knob, and to alocked state for inhibiting the longitudinal displacement of the controlknob. The device further includes an exchangeable drive shaft cartridgehaving a drive shaft extending between a proximal end and a distal end,and through an opening in a distal section of the drive shaft cartridge.The drive shaft cartridge includes a gear engagement assembly having adrive shaft gear fixedly attached to the proximal end of the driveshaft. Certain embodiments of the device include a first connector forremovably and pivotally connecting the prime mover carriage and the gearengagement assembly to one another and for aligning at least the primemover gear and the drive shaft gear with one another. Some embodimentsof the first connector include complementary first and second sections,wherein the first section is integrally formed with the prime movercarriage, and the second section is integrally formed with the gearengagement assembly. The device further includes a second connector forremovably connecting the handle and the drive shaft cartridge to oneanother, wherein removably connecting the handle and the drive shaftcartridge using the second connector removably meshes the prime movergear and the drive shaft gear, such that a rotational movement of one ofthe prime mover and the drive shaft induces a rotational movement in theother.

Yet another embodiment of a rotational atherectomy device includes ahandle having a proximal section, a distal section having a channelextending proximally from an opening in a distal end of the handle, andan elongated hollow intermediate section between the proximal and thedistal sections. The intermediate section includes an opening between aninterior thereof and the channel in the distal section, and a slot.Embodiments of the device include a prime mover carriage having a primemover, and a prime mover gear fixedly attached to a shaft of the primemover. In certain embodiments, the prime mover carriage is disposedwithin the interior of the intermediate section. Some embodiments of thedevice include a control knob having at least a portion thereofextending through the slot and operationally coupled to the prime movercarriage such that a longitudinal displacement of the control knobinduces a longitudinal displacement of the prime mover carriage. Incertain embodiments, the control knob can be operated to an unlockedstate for permitting the longitudinal displacement of the control knob,and to a locked state for inhibiting the longitudinal displacement ofthe control knob. Embodiments of the device further include anexchangeable drive shaft cartridge having a proximal section and adistal section, a drive shaft extending between a proximal end and adistal end. The drive shaft extends through an opening in the distalsection of the drive shaft cartridge. The drive shaft cartridge includesa gear engagement assembly having a drive shaft gear fixedly attached tothe proximal end of the drive shaft. Some embodiments of the deviceinclude a first connector for removably and pivotally connecting thehandle and the drive shaft cartridge to one another, and a secondconnector for removably connecting the handle and the drive shaftcartridge to one another.

In some embodiments of the device, the first connector is a pivotingconnector having complementary first and second sections, wherein thefirst section is integrally formed with the distal section of thehandle, and the complementary second section is integrally formed withthe drive shaft cartridge. In certain embodiments, the second connectorincludes complementary first and second sections, wherein the firstsection is integrally formed with the handle, and the second section isintegrally formed with the proximal section of the drive shaftcartridge. Removably connecting the handle and the drive shaft cartridgeusing the second connector removably meshes the prime mover gear and thedrive shaft gear, such that a rotational movement of one of the primemover and the drive shaft induces a rotational movement in the other.

In certain embodiments of the device, the first connector is a pivotingconnector having complementary first and second sections, wherein thefirst section is integrally formed with the handle, and the secondsection is integrally formed with the proximal section of the driveshaft cartridge. In some embodiments, the second connector includescomplementary first and second sections, wherein the first section isintegrally formed with the distal section of the handle, and the secondsection is integrally formed with the drive shaft cartridge. At leastthe prime mover gear and the drive shaft gear are aligned with oneanother when the handle and the drive shaft cartridge are removably andpivotally connected using the first connector. Removably connecting thehandle and the drive shaft cartridge using the second connectorremovably meshes the prime mover gear and the drive shaft gear, suchthat a rotational movement of one of the prime mover and the drive shaftinduces a rotational movement in the other.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1A is a perspective view of an embodiment of a rotationalatherectomy device;

FIG. 1B illustrates the device of FIG. 1A in an unloaded state;

FIG. 1C is a longitudinal cross-sectional view of the device of FIG. 1A;

FIG. 1D is a perspective view of an embodiment of an exchangeable driveshaft cartridge for the device of FIG. 1A;

FIG. 1E is a perspective view of the drive shaft cartridge of FIG. 1Dillustrating a drive shaft in a telescoped state;

FIG. 1F is a longitudinal cross-sectional view of at least a portion ofa distal section of the drive shaft cartridge of FIG. 1D;

FIG. 2A is a detailed longitudinal cross-sectional view of an embodimentof a prime mover carriage within the unloaded device of FIG. 1B;

FIG. 2B is a detailed longitudinal cross-sectional view of the primemover carriage of FIG. 2A with the exchangeable drive shaft cartridge ofFIG. 1D attached thereto;

FIG. 2C is a detailed perspective view of a proximal section of theexchangeable drive shaft cartridge of FIG. 1D;

FIG. 3A is a longitudinal cross-sectional view illustrating embodimentsof a prime mover carriage and a gear engagement assembly in an un-meshedstate;

FIG. 3B is a longitudinal cross-sectional view illustrating the primemover carriage and the gear engagement assembly of FIG. 3A in aun-meshed state;

FIG. 4A is a perspective view of a distal section in an embodiment of anexchangeable drive shaft cartridge for another embodiment of arotational atherectomy device;

FIG. 4B is a cross-section view of a portion of the distal section ofFIG. 4A;

FIG. 4C is a perspective view of a handle configured for removablyconnecting with the distal section of FIG. 4A;

FIG. 4D is a top view of a distal section of the handle of FIG. 4C;

FIG. 5 is a perspective view of another embodiment of a rotationalatherectomy device in a dis-assembled state;

FIG. 6 is a perspective view of yet another embodiment of a rotationalatherectomy device in a dis-assembled state;

FIG. 7A is a perspective view of an embodiment of a rotationalatherectomy device;

FIG. 7B is a side view illustrating an embodiment of a pivotingconnector for a prime mover carriage and an exchangeable drive shaftcartridge in the device of FIG. 7A;

FIG. 8 is a side view of another embodiment of a rotational atherectomydevice;

FIG. 9 is a side view of yet another embodiment of a rotationalatherectomy device; and

FIG. 10 is a block diagram representation of an embodiment of a systemfor performing an atherectomy procedure.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description of the various embodimentsillustrated in the appended figures, like components and elements areidentified using like reference numerals.

FIGS. 1A and 1B, respectively, are perspective views of an embodiment ofa rotational atherectomy device 100 in a “loaded” and an “unloaded”state, and FIG. 1C is a longitudinal cross-sectional view the device 100in the “loaded” state. The device 100 includes a handle 102 and anexchangeable drive shaft cartridge 104 that can be removably connectedto one another. The device 100 is considered to be in the “loaded” statewhen the handle 102 and the drive shaft cartridge 104 are connected toone another, and is considered to be in the “unloaded” state when thehandle 102 and the drive shaft cartridge 104 are separated from oneanother. The drive shaft cartridge 104 is referenced as “exchangeable”because the device 100 is configured for enabling an operator to usedifferent drive shaft cartridges with the same handle 102.

In some embodiments, the handle 102 includes a proximal section 106, adistal section 108, and an elongated hollow intermediate section 110extending between the proximal and distal sections 106 and 108,respectively. In some embodiments, the distal section 108 includes achannel 112 extending proximally from an opening 114 in a distal end 116of the handle 102. The channel 112 and the opening 114 are configuredfor passage therethrough of at least a portion of the drive shaftcartridge 104. The intermediate section 110 includes an opening 118between a longitudinally extending interior 120 of the intermediatesection 110 and the channel 112 in the distal section 108. The opening118 is also configured for passage therethrough of at least a portion ofthe drive shaft cartridge 104. The intermediate section 110 furtherincludes a longitudinally extending slot 122 extending into the interior120.

The interior 120 is configured for housing and for the longitudinaldisplacement therewithin of a prime mover carriage 124. As furtherdescribed elsewhere with reference to FIGS. 2A and 2B, the prime movercarriage 124 includes a prime mover 126 having a prime mover gear 128fixedly attached to a shaft 130 of the prime mover 126. In someembodiments, the prime mover 126 is a turbine that can be operated usinga variety of means including fluids such as liquid and compressed gas.In other embodiments, the prime mover 126 is an electric motor that canbe operated using a variety of electrical sources including an alternatecurrent (AC) source and a direct current (DC) source.

The device 100 further includes at least one control knob 132 having aportion 134 extending through the slot 122 and operationally coupled tothe prime mover carriage 124. Accordingly, a longitudinal displacementof the control knob 132 as indicated by the arrow 136 will induce alongitudinal displacement of the prime mover carriage 124, and the primemover 126 included therewith. In some embodiments, a position of theprime mover carriage 124 within the intermediate section 110 can befixed or locked, as needed, using the control knob 132. For instance,the control knob 132 can be operated into a locked state for inhibitingthe longitudinal displacement of the control knob 132 and of the primemover carriage 124 coupled thereto. The longitudinal displacement of thecontrol knob 132, and of the prime mover carriage 124 coupled thereto,can be enabled or permitted by operating the control knob 132 into anunlocked state. In some embodiments, the locked and unlocked state areattained by rotating the control knob 132. In alternate embodiments, thecontrol knob 132 can be operated in a different manner for providing thedescribed functionality. In other embodiments, alternativeconfigurations can be included for fixing or locking the position of theprime mover carriage 124, wherein the control knob 132, or some othermeans, is used for the longitudinal displacement of the prime movercarriage 124. All alternatives as may become apparent to those havingordinary skill in the art are considered as being within the metes andbounds of the instant disclosure.

FIG. 1D is a perspective view of an embodiment of the exchangeable driveshaft cartridge 104. As illustrated, the exchangeable drive shaftcartridge 104 includes a proximal section 138, a distal section 140, adrive shaft 142, and a gear engagement assembly 144. The drive shaft 142includes a proximal end and a distal end, and extends through an opening146 in the distal section 140. In some embodiments, the opening 146 isthrough a distal end of the drive shaft cartridge 104. However, this isneither required or necessary. For instance, in alternate embodiments,the drive shaft 142 can extend through an opening in a side of thedistal section 140. The gear engagement assembly 144 includes a driveshaft gear 148 fixedly attached to the proximal end of the drive shaft142 such that rotating the drive shaft gear 148 will rotate the driveshaft 142.

In some embodiments, the prime mover gear 128 and the drive shaft gear154 can be removably meshed (or engaged). As such, when the gears aremeshed, operating the prime mover 126 will induce a rotational movementin the prime mover gear 128, the drive shaft gear 148 and the driveshaft 142. The rotational movement of the drive shaft 142 can be stoppedby un-meshing (or disengaging) the prime mover gear 128 and the driveshaft gear 148 and/or by stopping the prime mover 126. As will beapparent to those having ordinary skill in the art, the rotational speedof the drive shaft 142 will be determined at least in part by the gearratio of the drive shaft gear 148 to the prime mover gear 128 and by therotational speed of the prime mover 126. In certain embodiments, theprime mover gear 128 and the drive shaft gear 148 are substantiallysimilar in that they are of the same diameter and have the same numberof teeth. In such embodiments, the prime mover gear 128 and the driveshaft gear 148 will have substantially similar rotational speeds. Inother embodiments, the prime mover gear 128 and the drive shaft gear 148can have different rotational speeds such that one of the two meshedgears rotates faster or slower than the other. As will be apparent tothose having ordinary skill in the art, this can be accomplished bydecreasing the diameter and increasing the number of teeth for one ofthe two gears relative to the other. While the embodiments describe andillustrate only one prime mover gear 128 and only one drive shaft gear142, such arrangements and quantities of gears should not be consideredas limiting. For instance, although not shown, some embodiments of thedevice 100 may include a gear box having one or more additional gearsmeshed with the one prime mover gear 128 and the one drive shaft gear148.

In some embodiments, the prime mover 126 and the drive shaft 142 arerotatably coupled with a mechanism that can both engage and disengagethe prime mover 126 and the drive shaft 142 from one another. In anon-limiting exemplary embodiment, the mechanism is a clutch mechanism,including a magnetic clutch.

In order to use the device 100, it must be “loaded” by connecting thehandle 102 and the drive shaft cartridge 104 to one another such thatthe prime mover gear 128 and the drive shaft gear 148 are meshed. Insome embodiments, this is accomplished by inserting at least the gearengagement assembly 144 into the handle 102 and juxtaposing it with theprime mover carriage 124.

The channel 112 and the openings 114 and 118 are configured for passagetherethrough of at least the gear engagement assembly 144. The gearengagement assembly 144 is inserted into the opening 114, advancedthrough the channel 112 and the opening 118, and into the interior 120of the intermediate section 110. Thereafter, the prime mover carriage124 and the gear engagement assembly 144 are advanced towards oneanother, either in combination or individually one towards the other,until the prime mover gear 128 and drive shaft gear 148 are aligned withone another. In some embodiments, before the gear engagement assembly144 is advanced through the opening 118, the prime mover carriage 124 isdisplaced towards the opening 118 and held thereat by operating thecontrol knob 132 to its locked state. Thereafter, the gear engagementassembly 144 is advanced through the opening 118 until the prime movergear 128 and drive shaft gear 148 are aligned with one another.

For ensuring alignment of the prime mover gear 128 and drive shaft gear148, some embodiments of the device 100 include at least one alignmentelement for guiding at least the gear engagement assembly 144. In someembodiments of the device 100, at least a portion of an alignmentelement is provided in one or more of the channel 112, the openings 114and 118, the interior 120, the prime mover carriage 124, and the gearengagement assembly 144. In certain embodiments of the device 100, thealignment element can include at least a first and a secondcomplementary section, wherein the first section is disposed on the gearengagement assembly 144 and the second section is disposed on any one ormore of the channel 112, the openings 114 and 118, the interior 120, andthe prime mover carriage 124. For instance, the alignment element mayinclude a tongue-and-groove configuration, wherein the first section,i.e., the tongue, is disposed on the gear engagement assembly 144 andthe second section, i.e., the groove, is contiguously or sectionally(e.g., piece-wise) disposed on one or more of the channel 112, theopenings 114 and 118, the interior 120, and the prime mover carriage124. Of course, the components or elements of the device 100 on whichthe tongue and the groove are disposed can be reversed. It should beappreciated that it is not always necessary or a requirement that thealignment element include both a first and a section. In someembodiments, the components and/or elements of the device 100 can beconfigured such that only one section of the alignment element isrequired. Some non-limiting examples for the alignment element includeone or more ramps, ribs, rails, and channels. All alternativeconfigurations for the alignment element as may become apparent to thosehaving ordinary skill in the art are considered as being within themetes and bounds of the instant disclosure.

A non-limiting exemplary embodiment of an alignment element having firstand second complementary sections is illustrated in FIGS. 2A-2C. FIG. 2Ais a detailed cross-sectional view illustrating a state of the primemover carriage 124 without the gear engagement assembly 144 attachedthereto; FIG. 2B is a detailed cross-sectional view illustrating a stateof the prime mover carriage 124 with the gear engagement assembly 144attached thereto; and FIG. 2C is a close-up perspective view of theproximal section 138 of the drive shaft cartridge 104. In theillustrated embodiment, the alignment element includes a first and asecond section. The first section, disposed on the prime mover carriage124, is defined at least in part by an insertion channel 150. In someembodiments, the insertion channel 150 is defined at least in part byfirst and second guides 152 and 154, respectively. In some embodiments,the second guide 154 is defined at least in part by a ramped planarsurface having a thickness that increases from a distal end to aproximal end of the second guide 154. The second section of thealignment element, illustrated in FIG. 2C, is disposed on at least theproximal section 138 of the drive shaft carriage 104. In the illustratedembodiment, the second section is defined at least in part by one ormore indents 156, 158 configured for slidable engagement with one orboth of the first and second guides 152 and 154.

In some embodiments, the device 100 includes at least one biasingelement for meshing the aligned prime mover gear 128 and the drive shaftgear 154 such that when the gears are meshed, a rotational movement ofone of the prime mover 126 and the drive shaft 142 will induce arotational movement in the other. In some embodiments, the at least onebiasing element displaces at least the prime mover gear 126 towards alocation whereat the drive shaft gear 142 will be positioned when thegears 126 and 142 are aligned. In other embodiments, the at least onebiasing element displaces at least the drive shaft gear 142 towards alocation whereat the prime mover gear 126 will be positioned when thegears 126 and 142 are aligned. In alternate embodiments, the device 100can include one or more biasing elements configured for displacing boththe prime mover gear 126 and the drive shaft gear 142 towards oneanother when the gears 126 and 142 are aligned. Non-limiting examples ofbiasing elements include compression springs, coil springs, leafsprings, and other suitable components and/or materials.

FIGS. 2A and 2B illustrate a non-limiting exemplary embodiment of thedevice 100 having a spring 160 biasing element configured for biasing atleast the prime mover gear 128 towards the drive shaft gear 148. Whenthe device 100 is not loaded and/or the prime mover carriage 124 and thegear engagement assembly 144 are not juxtaposed, the spring 160 pushesat least the prime mover gear 128 towards the location whereat the driveshaft gear 148 will be positioned when the gears 128 and 148 will bealigned when the device 100 is loaded. The alignment element isconfigured for inhibiting or minimizing roll, pitch and yaw of the gearengagement assembly 144 and the prime mover carriage 124 as they areadvanced towards one another when loading the device 100. As the leadingedge of the gear engagement assembly 144 enters the insertion channel150 and the prime mover gear 128 and the drive shaft gear 148 advancetowards each other, the ramped planar surface of the second guide 154causes the proximal section of the prime mover carriage 124, and atleast the prime mover gear 128, to move in a direction away from theadvancing drive shaft gear 148. When the prime mover carriage 124 andthe gear engagement assembly 144 are appropriately juxtaposed, the primemover gear 128 and the drive shaft gear 148 will be aligned, and thegears 128 and 148 will mesh because of the biasing force from the spring160. While only one spring 160 is illustrated and described withreference to the FIGS. 2A and 2B, it should be readily apparent thatmore than one spring can be used for providing the requiredfunctionality. Accordingly, all such alternatives are considered asbeing within the metes and bounds of the instant disclosure.

In some embodiments, the prime mover carriage 124 includes one or morealignment pins 162 and the gear engagement assembly 144 includes one ormore correspondingly aligned apertures configured for receiving the oneor more alignment pins 162. The one or more alignment pins 162 and theone or more apertures are configured and located such that when theprime mover carriage 124 and the gear engagement assembly 144 areproperly juxtaposed, the prime mover gear 128 and the drive shaft gear148 will be aligned as required, and the one or more alignment pins 162and the corresponding aperture will engage. Accordingly, furtherrelative displacement of the prime mover carriage 124 and the gearengagement assembly 144 will be inhibited and the alignment of the gears128 and 148 will be maintain. Spring forces from the one or more biasingelements will mesh the prime mover gear 128 and the drive shaft gear148.

In some embodiments, the drive shaft cartridge 104 includes a releasablelocking feature that engages with a releasable locking feature on atleast one of the handle 102 and the prime mover carriage 124. In someembodiments, a self-releasing locking mechanism 204 is provided at ornear the proximal end of the prime moving carriage 124. In theembodiment shown, the self-releasing locking mechanism 204 is positionedproximal of the prime mover gear 128. In some embodiments, at least aportion of the proximal section 138 of the drive shaft cartridge 104 isengaged with the self-releasing locking mechanism 204. In someembodiments, the handle 102 also has a self-releasing locking mechanism206 within channel 208. In certain embodiments, the one or moreself-releasing locking mechanisms 204 and 206 are configured forinhibiting the displacement or movement of the prime mover carriage 124while it is not connected with the drive shaft cartridge 104. When thedevice 100 is “loaded” and the prime mover gear 138 and the drive shaftgear 148 are meshed, the one or more self-releasing locking mechanisms204 and 206 is disengaged.

FIG. 1B illustrates an alternate embodiment of an elongated biasingelement 164 that may also be used as an alignment element. The biasingelement 164 includes a distal end fixedly or removably attached to orintegrally formed with the drive shaft cartridge 104 at a locationdistal from the gear engagement assembly 144. In certain embodiments,the biasing element 164 extends proximally and is configured such thatin the absence of any external force, a proximal end 166 thereof extendsaway from the gear engagement assembly 144. When appropriate force isapplied on at least a portion of the biasing element 164, the proximalend 166 is displaced in the direction indicated by the arrow 168 towardsthe gear engagement assembly 144 and spring force is stored in thebiasing element 164. Then, when the applied force is removed, the storedspring force will urge the proximal end 166 away from the gearengagement assembly 144 in the direction opposite that indicated by thearrow 168.

Additionally, in some embodiments, the biasing element 164 can beconfigured as the first section of an alignment element, and the secondsection of the alignment element can be disposed on at least a portionof the handle 102. The second section can be a groove or similarstructure configured for slidable engagement with the biasing element164. In some embodiments, the second element is disposed on, e.g.,integrally formed with, the prime mover carriage 124. Additionally, orin the alternative, at least a portion of the handle 102 distal from theprime mover carriage 124 can include the second section of the alignmentelement. For example, the second section can be disposed on at least oneor more of the opening 114 in the distal end 116 of the handle 102,portions of or the entire channel 112 extending proximally from theopening 114, the opening 118 in the intermediate section 110, and atleast a portion of the interior 120 proximal of the opening 118.

In some embodiments, the second section of the alignment element caninclude an indent 170 configured for removably receiving the proximalend 166 of the biasing element 164 and inhibiting further displacementof the drive shaft cartridge 104 in the proximal direction within thehandle 102. In particular, the displacement of the gear engagementassembly 144 in the proximal direction within the handle 102 isinhibited. Accordingly, it should be readily apparent that the proximalend 166 and the indent 170 must have complementary configurations suchthat the prime mover gear 128 and the drive shaft gear 148 are alignedwhen the proximal end 166 is removably received within the indent 170.For loading the device 100, the proximal end 166 and the gear engagementassembly 144 are displaced towards one another and both are theninserted through the opening 114 into the handle 102. The gearengagement assembly 144 and the prime mover carriage 124 are displacedtowards one another until the proximal end 166 of the biasing element164 is removably received within the indent 170. The prime mover gear128 and the drive shaft gear 148 will be aligned with one another, andthe spring force stored within the biasing element 164 will cause thegears 128 and 148 to mesh.

Some embodiments of the device 100 can include one or more releasemechanisms for separating, e.g., un-meshing, the meshed gears 126 and142 so that the exchangeable drive shaft cartridge 104 can be removedfrom the handle 102. In other embodiments of the device 100, one or moreof the handle 102, the drive shaft cartridge 104 and the alignmentelement can be configured such that a displacement of the handle 102 andthe drive shaft cartridge 104 away from one another will separate thejuxtaposed prime mover carriage 124 and the gear engagement assembly 144and also separate, e.g., un-mesh, the meshed gears 126 and 142.

FIGS. 3A and 3B are partial side views of an embodiment for meshing theprime mover gear 128 and the drive shaft gear 148 with one another in anembodiment of the device 100. As described elsewhere, embodiments of thedevices disclosed herein, e.g., device 100, include a handle defined atleast in part by an elongated hollow intermediate section. FIG. 3Aillustrates a portion of an interior 302 within an embodiment of anelongated hollow intermediate section of a handle, e.g., handle 102. Aswith interior 120, the interior 302 is configured for housing and for alinear displacement of a gear engagement assembly 304 and a prime movercarriage 306. In several respects the embodiments of the gear engagementassembly 304 and of the prime mover carriage 306, respectively, aresubstantially similar to the gear engagement assembly 144 and the primemover carriage 124 described elsewhere with reference to the device 100.As such, the gear engagement assembly 304 includes a drive shaft gear308 fixedly attached to a proximal end of a drive shaft extendingdistally therefrom. And, the prime mover carriage 306 includes a primemover 310 having a prime mover gear 312 fixedly attached to a shaft 314thereof.

As shown, the interior 302 includes a guide rail 316 extending throughat least a portion thereof. In some embodiments, the guide rail 316divides the interior 302 into at least a first section 318 and a secondsection 320. As illustrated, the first section 318 is configured foraccommodating the gear engagement assembly 304 and the prime movercarriage 306 while the drive shaft gear 308 and the prime mover gear 312are aligned with one another but are not meshed. The second section 320is configured for accommodating the gear engagement assembly 304 and theprime mover carriage 306 after the drive shaft gear 308 and the primemover gear 312 are meshed. The guide rail 316 further includes atransition section 322 extending between the first and the secondsections 318 and 320, respectively. In some embodiments, the transitionsection 322 is configured for advancing at least the aligned drive shaftgear 308 and the prime mover gear 312 towards one another while the gearengagement assembly 304 and the prime mover carriage 306 are displaced,either singularly or in combination, from the first section 318 into thesecond section 320. As will be apparent, the transition section 322 istherefore configured for meshing the aligned drive shaft gear 308 andthe prime mover gear 312 when they are displaced from the first section318 into the second section 320. In the illustrated embodiment, whilethe gear engagement assembly 304 and the prime mover carriage 306 aretogether displaced from the first section 318 into the second section320, the transition section 322 causes the prime mover carriage 306 topivot about a pivot point 324 such that at least the prime mover gear312 is displaced towards, and meshed with, the drive shaft gear 308. Insome embodiments, reversing the displacement of the gear engagementassembly 304 and the prime mover carriage 306 from the second section320 into the first section 318 will un-mesh the drive shaft gear 308 andthe prime mover gear 312 from one another. The drive shaft cartridge ofwhich the gear engagement assembly 304 is a component of, can be removedfrom the handle and replaced with a different or another similar driveshaft cartridge having a gear engagement assembly substantially similarto the gear engagement assembly 304.

In the first section 318 of the embodiment illustrated in FIG. 3A, theprime mover carriage 306 is shown tilted about the pivot point 324 suchthat the drive shaft gear 308 and the prime mover gear 312 are separatedfrom, and not meshed with, one another. In some embodiments, theillustrated tilting of the prime mover carriage 306 may be due togravitational forces. Although not shown, other embodiments can includeone or more biasing elements configured to tilt the prime mover carriage306 as illustrated. Non-limiting exemplary biasing elements includecoiled springs, leaf springs and similar components configured to storespring forces when displace from their “normal” state. For instance, oneor more coil springs, each having a compressed state as its “normal”state, may be provided whereby, in the first section 318, the primemover carriage 306 is tilted as illustrated in FIG. 3A. Displacing theprime mover carriage 306, with the gear engagement assembly 304, intothe second section 320, as illustrated in FIG. 3B, will “stretch” theone or more springs and store spring forces therewithin. The subsequentdisplacement of the prime mover carriage 306, with the gear engagementassembly 304, from the second section 320 into the first section 318will “release” the spring forces whereby the prime mover carriage 306will tilt as illustrated in FIG. 3A, and the drive shaft gear 308 andthe prime mover gear 312 will un-mesh, i.e., separate from one another.

In order to use the device 100, the distal section 108 of the handle 102and the distal section 140 of the drive shaft cartridge 104 need becoupled to one another such that during use, the prime mover gear 128and the drive shaft gear 148 remain meshed with one another within thehandle 102. To that end, embodiments of the device 100 may include oneor more connectors and associated release mechanisms, respectively,configured for engaging and separating or disengaging the handle 102 andthe drive shaft cartridge 104 from one another. As stated, such couplingneeds to be releasable because it may be desirable or necessary toreplace the drive shaft cartridge 104 during the procedure. Accordingly,some embodiments of the one or more connectors include complementaryfirst and second sections that can be integrally formed, respectively,with the distal section 108 of the handle 102 and with the distalsection 140 of the drive shaft cartridge 104. The first and secondsections are configured for being removably coupled to each other. Itwill be readily apparent to one skilled in the art that the component onwhich the first and the second sections are formed can be reversedwithout affecting the required functionality. In other words, thefunctionality of the connector will not change if the first section isintegrally formed with the distal section 140 of the drive shaftcartridge 104 and the second section integrally formed with the distalsection 108 of the handle 102.

FIGS. 1A and 1B illustrate an embodiment of a connector configured forkeeping the handle 102 and the drive shaft cartridge 104 connected toone another while the device 100 is in use. The connector includes atabbed connector 172 integrally formed with the distal section 140 ofthe drive shaft cartridge 104 and one or more complementary holes 176integrally formed with the distal section 108 of the handle 102. Thetabbed connector 172 includes one or more tabs 174, each of whichremovably engages with a complementary hole 176 in the distal section108. When the device 100 is “loaded,” i.e., the distal sections 108 and140 abut one another, the tabbed connector 172 prevents separation ofthe handle 102 and the drive shaft cartridge 104 while the device 100 isin use during a procedure. For “unloading” the device 100, i.e.,separating the handle 102 and the drive shaft cartridge 104 from oneanother, the distal sections 108 and 140 can be disengaged from oneanother by applying pressure to the tabs 174 in the direction indicatedby the arrows 178, and displacing the distal sections 108 and 140 awayfrom one another.

In some embodiments, when the exchangeable drive shaft cartridge 104 isloaded, and the prime mover gear 128 and the drive shaft gear 148 areproperly meshed and engaged with one another, a gap may exist betweenthe distal section 140 of the drive shaft cartridge 104 and the distalend 116 of the handle 102. In some embodiments, the one or moreconnectors for removably connecting the distal end 116 of the handle 102and the distal section 140 of the drive shaft cartridge 104 with oneanother can include a sealing mechanism for creating a sealed couplingtherebetween.

Alternate exemplary embodiments of one or more connectors and associatedrelease mechanisms includes snap-fit connectors, tongue and grooveconnectors, rails, rotatable connectors, bayonet mounts and ribs. Forinstance, in a non-limiting exemplary embodiments, the sealing mechanism(i.e., the one or more connectors) can be a bayonet mount wherein arotational displacement of the handle 102 and/or the drive shaftcartridge 104 in opposite directions, after being juxtaposed, connectsor disconnects the handle 102 and the drive shaft cartridge 104 from oneanother.

In some embodiments, the one or more connectors for removably connectingthe handle 102 and the drive shaft cartridge 104 with one another isalso configured to function as a seal. For example, the one or moreconnectors can also form a fluidic seal that inhibits any flow of fluidtherethrough.

Other embodiments of one or more release mechanisms as may becomeapparent to those having ordinary skill in the art are considered asbeing within the metes and bounds of the instant disclosure.

As illustrated in FIGS. 1A-1C, the device 100 includes a guide wireclamp or brake 180 in the proximal section 106 of the handle 102.Engaging the guide wire clamp or brake 180 enables the user of thedevice 100 to stop the insertion or retraction of a guide wire 182extending through the device 100. When the guide wire clamp or brake 180is operated to its dis-engaged state, the guide wire 182 can then beinserted or retracted.

In some embodiments, the proximal section 106 of the handle 102 includesat least one control panel 184 through which the user can monitor and/orcontrol the operation of the device 100. Some embodiments of the atleast one control panel 184 enable the user of the device 100 to start,stop, change and monitor the rotational speed of the prime mover 126which affects the rotational speed of the drive shaft 142. Certainembodiments of the at least one control panel 184 enable the user of thedevice 100 to monitor and/or control the flow of saline. Someembodiments of the device 100 may include one or more fiber optic cablesextending into the vasculature of a patient. In such embodiments of thedevice 100, the at least one control panel 184 may be configured fordisplaying visuals, e.g., images, of the interior of the vasculature.Certain embodiments of the device 100 may include one or more sensorsfor sensing conditions such as whether or not the handle 102 and thedrive shaft cartridge 104 are properly coupled as required for operatingthe device 100. The one or more sensors may also include means forsensing parameters such as the environmental conditions (e.g.,temperature, pressure, etc.) within the vasculature and/or the physicalconditions (e.g., thickness, pliability, etc.) of the vasculature.Accordingly, some embodiments of the at least one control panels 184 maybe configured for displaying the sensed conditions. Certain embodimentsof the at least one control panels 184 may include at least amicro-processor, memory, display interfaces, input/output ports orinterfaces, etc. All functionalities of the at least one control panel184 as may become apparent to those having ordinary skill in the art areconsidered as being within the metes and bounds of the instantdisclosure.

As described elsewhere, certain embodiments of the device 100 includeone or more sensors for detecting whether or not the handle 102 and thedrive shaft cartridge 104 are properly connected. More specifically, theone or more sensors are configured to detect whether or not the distalend 116 of the handle 102 and the proximal end of the distal section 140are properly connected. If proper connection as required for operatingthe device 100 is not detected, the drive shaft 142 may be inhibitedfrom advancing and/or rotating. This is also applicable for embodimentswherein the drive shaft 142 is configured as a telescoping drive shaftas illustrated in FIG. 1E.

In some embodiments of the device 100, the distal section 140 of thedrive shaft cartridge 104 includes a nosecone 186. In embodiments of thedevice 100 wherein the drive shaft 142 is telescoping, the nosecone 186and the drive shaft cartridge 104 are configured for being removablyattached to one another. FIG. 1F illustrates an embodiment wherein thenosecone 186 includes a proximally extending structure 188 and the driveshaft cartridge 104 includes an output gear hypotube 190. As shown, aproximal section 192 of the structure 188 and a distal section 194 ofthe hypotube 190 include complementary elements 196 and 198,respectively, configured for removably connecting the structure 188 andthe hypotube 190 with one another. In some embodiments, thecomplementary elements 196 and 198 respectively include a spring-biasedtab and an indent configured for slidable engagement with one another.In certain embodiments, the spring-biased tab is configured as a leafspring. In other embodiments, the complementary elements 196 and 198respectively include a spring-biased ball and a depression configuredfor slidable engagement with one another. Of course, the configurationsof the complementary elements 196 and 198 can be reversed. Furthermore,the described and illustrated embodiments are exemplary and, as such,should not be construed as being limiting. Modifications or alternateembodiments for removably connecting the nosecone 186 and the hypotube190 are considered as being within the metes and bounds of the instantdisclosure.

In use, when the drive shaft 142 is in the retracted state and nottelescoping, the structure 188 and the hypotube 190 are connected orcoupled to one another at their respective proximal and distal sections192 and 194. In some embodiments, the device 100 must be “loaded” inorder to telescope the drive shaft 142. If the device 100 is “unloaded”,one or more locking mechanisms (not shown) inhibit the drive shaft 142from being telescoped. When the device 100 is “loaded”, the one or morelocking mechanism(s) are disengaged, and the drive shaft 142 can betelescoped by displacing the nosecone 186 and the handle 102 in oppositedirections away from each other.

In certain embodiments, the structure 188 and the hypotube 190 includecomplementary alignment elements for aiding the insertion of theproximal section 192 into the distal section 194. In the illustratedembodiment, the hypotube 190 includes an outwardly flaring distal end200, and the structure 188 includes an inwardly tapering proximal end202. The described embodiment should not be construed as being limiting.In alternate embodiments, the distal section 194 of the hypotube 190 canbe configured for insertion into and retraction from the proximalsection 192 of the structure 188.

Certain embodiments of the device 100 include a saline infusion port influid communication with a saline reservoir. The device may furtherinclude an internal saline tube configured for transporting the salinefrom the infusion port to an inner lumen of a catheter. As such, thesaline from the reservoir may be used for reducing friction between therotating drive shaft 142 and any non-rotating components disposed withinand/or around the drive shaft 142. The saline from the reservoir mayalso be used as a heat transfer fluid.

FIG. 4A is a perspective view of a distal section 402 in an embodimentof an exchangeable drive shaft cartridge for another embodiment of arotational atherectomy device. The distal section 402 includes a tubularsection 404 having a trough 406 extending proximally therefrom, and atubular nosecone 408 extending distally therefrom. The tube of thetubular section 404 is contiguous at its first open end with the trough406, and is contiguous at its second open end, opposite the first openend, with a first open end of the tube of the nosecone 408. A secondopen end, opposite the first open end, of the tube of the nosecone 408defines the opening 146 in a distal end 410 of the distal section 402.As such, the distal section 402 is configured for passage therethroughof the drive shaft 142 fixedly attached at its proximal end to the driveshaft gear 148 and having a distal end configured for insertion into avasculature of a patient. While the distal section 402 is illustrated ashaving a generally circular cross-section throughout, the geometricalshape should not be considered as a requirement and/or limiting.Alternate shapes extending the entire distal section 402 and/or onportions thereof are considered as being within the metes and bounds ofthe instant disclosure.

FIG. 4B is a cross-section view of the trough 406 along a planeextending through the sectional line B-B shown in FIG. 4A. In theillustrated embodiment, the trough 406 has a generally U-shaped geometryhaving a channel 412 defined at least in part by opposing walls 414 and416. However, this specific geometrical shape for the trough 406 shouldbe considered as a requirement and/or limiting. Alternate configurationsas may become apparent to those having ordinary skill in the art areconsidered as being within the metes and bounds of the instantdisclosure.

The distal section 402 is illustrated having a longitudinally extendingfin 418 on at least a portion thereof. In FIG. 4A, the fin 418 isillustrated as extending along the entire length of the tubular section404 and the trough 406. However, the longitudinal extent of the fine 418and/or its location on the external surface of the distal section 402should not be considered as a requirement and/or limiting. In someembodiments, the fin 418 extends along only portions of the tubularsection 404 and/or the trough 406. In certain embodiments, the fin 418,and/or portions thereof, are positioned at one or more locations on theexternal surface of the distal section 402. All alternative shapes,sizes, locations, etc., for the fin 418, as may become apparent to thosehaving ordinary skill in the art are considered as being within themetes and bounds of the instant disclosure.

With reference to FIGS. 4A and 1B, it should be apparent that therespective distal sections 402 and 140 of the drive shaft cartridges aresubstantially different from one another. Accordingly, the distalsections of the handles through which the drive shaft cartridges havingthe distal sections 402 and 140 are inserted for removable coupling withthe handle also need to be different from one another. FIG. 4C is aperspective view of an embodiment of a handle 420 having a distalsection 422 different from the distal section 108 of the handle 102illustrated in FIG. 1B. In several other aspects, the handles 420 and102 are substantially similar to one another. A top view of at least aportion of the distal section 422 proximate a distal end 424 of thehandle 420 is illustrated in FIG. 4D.

In general, the cross-section of the distal section 422 of the handle420 through which the drive shaft cartridge is inserted and thecross-section of at least the tubular section 404 of the distal section402 are complementary and/or substantially similar. As illustrated inFIG. 4D, the distal section 422 includes a channel 426 defined at leastin part by opposing guard rails or walls 428 and 430. The channel 426and the opposing guard rails 428 and 430 extend proximally from anopening 432 in the distal end 424, and are configured for slidablecoupling with at least the fin 418, the tubular section 404 and thetrough 406 of the distal section 402 of the drive shaft cartridge. Insome embodiments, the channel 426 and the opposing guard rails 428 and430 are configured for aligning the distal sections 402 and 422 with oneanother.

In some embodiments, the distal end 424 and at least a portion of thedistal section 422 proximal thereof is configured for removablyconnecting with at least a portion of the nosecone 408 of the distalsection 402. In certain embodiments, the device includes at least oneconnector having complementary first and second sections 434 and 436,respectively, disposed on the nosecone 408 and the distal section 422,and configured for connecting and dis-connecting the nosecone 408 andthe distal section 422.

For “loading” the device, the gear engagement assembly 144 is insertedthrough the opening 432 into the handle and is removably connected withthe prime mover carriage 124 housed within the interior 120 in theintermediate section 110 of the handle 420. As described elsewhere, theprime mover gear 128 and the drive shaft gear 148 will mesh when theprime mover carriage 124 and the gear engagement assembly 144 areconnected with one another. Next, as indicated by the directional arrow438, the trough 406 and the tubular section 404 of the distal section402 are inserted into the distal section 422 of the handle 420 throughthe opening 432. The distal section 402 and at least the distal section422 of the handle 420 are displaced in opposite directions towards eachother until the first and second sections 434 and 436 of the connectorengage one another. In the illustrated embodiment, to “unload” thedevice, for example to change or replace the drive shaft cartridge, thedistal section 402 and at least the distal section 422 of the handle 420are displaced in opposite directions away from each other whileconcurrently pushing or pressing at least the first section 434 of theconnector in the direction indicated by the arrow 440. Concurrently, orsubsequently, the gear engagement assembly 144 and the prime movercarriage 124 are disconnected and the gear engagement assembly 144 isremoved from the handle 420 through the opening 432.

FIG. 5 is a perspective view of another embodiment of a rotationalatherectomy device 500 in a dis-assembled state. Elements and componentsof the device 500 that are substantially similar or the same as those inother embodiments of the device are identified with the same referencenumerals. The device 500 includes a handle 502 and an exchangeable driveshaft cartridge 504, wherein the handle 502 and the drive shaftcartridge 504 include one or more connectors configured for removablyconnecting the handle 502 and the drive shaft cartridge 504 to oneanother.

Some embodiments of the handle 502 include a proximal section 106, adistal section 508, and an elongated intermediate section 510. Thedistal section 508 includes a channel 512 extending proximally from anopening 514 in a distal end 516 of the handle 502. Certain embodimentsof the intermediate section 510 include a trough 518 extending betweenthe proximal and distal sections 106 and 508, respectively, of thehandle 502. The trough 518 is configured for housing and longitudinaldisplacement of a prime mover carriage 520 disposed therewithin. Theprime mover carriage 520 includes a prime mover 522 and a prime movergear 524 fixedly attached to a shaft of the prime mover 522.

Certain embodiments of the drive shaft cartridge 504 include a proximalsection 526, a distal section 528, and an intermediate section 530having a slot 532 extending longitudinally between the proximal anddistal sections 526 and 528, respectively. The drive shaft cartridgefurther includes at least one control knob 534 having at least a portionthereof extending through the slot 532 and operationally coupled to agear engagement assembly 536. Operationally and functionally, thecontrol knob 534 is substantially similar to the control knob 132 of thedevice 100. In particular, longitudinal displacement of the control knob534 along the slot 532 will induce a similar longitudinal displacementof the gear engagement assembly 536. As with the control knob 132, thecontrol knob 534 can be operated between locked and unlocked states. Thegear engagement assembly 536 includes a drive shaft gear 538 fixedlyattached to a proximal end of a drive shaft extending distally therefromand through an opening in the distal section 528 of the drive shaftcartridge 504.

In order to use the device 500, the handle 502 and the exchangeabledrive shaft cartridge 504 may be removably connected to each other asfollows. The control knob 534 is used for proximally displacing the gearengagement assembly 536 and positioning it proximate to and/or withinthe proximal section 526 of the drive shaft cartridge 504. In someembodiments, such as that illustrated in FIG. 5, the gear engagementassembly 536 may be positioned such that a portion thereof and/or thedrive shaft gear 538 extends proximally beyond the proximal end 544.Also as illustrated, the prime mover carriage 520 is located proximate adistal end 546 of the trough 518. The prime mover gear 524 and the driveshaft gear 538 are aligned and then meshed by juxtaposing the primemover carriage 520 and the gear engagement assembly 536. Concurrently,the handle 502 and the drive shaft cartridge 504 are displaced towardsone another until the proximal end 544 of the proximal section 526(i.e., the drive shaft cartridge 504) and the distal end 542 of theproximal section 506 are removably coupled. Some embodiments of thedevice 500 may include complementary sections of one or more alignmentelements for assisting with and/or maintaining the alignment of theprime mover gear 524 and the drive shaft gear 538. Non-limitingexemplary embodiments of the one or more alignment elements includetongue-and-groove, rails, channels and ribs. Certain embodiments of thedevice 500 may include complementary sections of one or more connectorsfor removably coupling the prime mover carriage 520 and the gearengagement assembly 536. Non-limiting exemplary embodiments of the oneor more connector include tabbed connectors and snap-fit connectors.

Embodiments of the device 500 include one or more connectors havingcomplementary first and second sections configured for removablycoupling (or connecting) the handle 502 and the drive shaft cartridge504 to each other. Some embodiments of the connector include one or moreslidable tabs 540 integrally formed with the proximal section 506 of thehandle 502 and complementary tab receptors (not shown) integrally formedwith a proximal section 526 of the drive shaft cartridge 504. While FIG.5 illustrates only one slidable tab 540 at a distal end 542 of theproximal section 506, this should not be construed as being limiting. Itshould be realized that most embodiments of the device 500 will includeone or more additional slidable tabs integrally formed with the proximalsection 506 at the distal end 542 thereof. For example, the proximalsection 506 may include a slidable tab on the side or wall opposite theside or wall on which the slidable tab 540 is illustratively disposed.Additionally, or in the alternative, the distal end 542 of the proximalsection 506 may include a slidable tab integrally formed on the sameside or wall on which the control panel 184 is illustratively disposed.Although not shown in FIG. 5, it should be readily apparent that foreach of the one or more slidable tabs 540, the drive shaft cartridge 504will include a complementary tab receptor integrally formed with theproximal section 526 at a proximal end 544 thereof. Of course, it isneither necessary nor a requirement that the one or more connectorsinclude complementary slidable tabs 540 and tab receptors. Alternativeconfigurations of the one or more connectors as may become apparent tothose having ordinary skill in the art are considered as being withinthe metes and bounds of the instant disclosure. For example, the one ormore connectors may include snap-fit connectors and tongue and grooveconnectors.

Some embodiments of the device 500 may include one or more alternativeand/or additional connectors having first and second sections configuredfor removably coupling (or connecting) the handle 502 and the driveshaft cartridge 504 to each other. The handle 502 may be considered as alower section of the device 500, and the drive shaft cartridge 504 maybe considered as an upper section of the device 500. For example, theembodiment of the device 500 illustrated in FIG. 5 includes a firstsection 546 integrally formed with the distal section 508 of the handle502, and a complementary second section (not shown) integrally formedwith the distal section 528 of the drive shaft cartridge 504. The firstand second sections of such connectors are configured for removablycoupling at least the distal sections 508 and 528, respectively, of thehandle 502 and the drive shaft cartridge 504. In some embodiments, suchas that illustrated in FIG. 5, the handle 502 and the drive shaftcartridge 504 are displaced towards one another as indicated by thedirectional arrow 548, and are thereafter removably coupled by displacedthe distal sections 508 and 528 towards one another as indicated by thedirectional arrow 550. In some embodiments, the connector at the distalsection of the device 500 (i.e., in the distal sections 508 and 528) maybe further configured as an alignment element such as atongue-and-groove connector for slidable coupling with or without snapconnectors or tab connectors. In certain embodiments, the device 500 mayinclude additional and/or alternative alignment elements and/orconnectors, each having complementary first and second sectionsintegrally formed with the longitudinally extending opposing side edgesof the handle 502 and the drive shaft cartridge 504. For example, thefirst sections may be integrally formed with the opposing side edges 552and 554 of the handle 502, with the complementary second sections,respectively, integrally formed with the opposing side edge 556 and theside edge not shown of the drive shaft cartridge 504. All alternativeconfigurations for the one or more connectors and/or the one or morealignment elements as may become apparent to those having ordinary skillin the art are considered as being within the metes and bounds of theinstant disclosure.

FIG. 6 is a perspective view of yet another embodiment of a rotationalatherectomy device 600 in a dis-assembled state. Elements and componentsof the device 600 that are substantially similar or the same as those inother embodiments of the device are identified with the same referencenumerals. Device 600 includes a handle 602 and an exchangeable driveshaft cartridge 604, wherein the handle 602 and the drive shaftcartridge 604 include one or more connectors configured for removablyconnecting the handle 602 and the drive shaft cartridge 604 to oneanother. The handle 602 includes a proximal section 106, a distalsection 606, and an elongated hollow intermediate section 110 extendingbetween the proximal and distal sections 106 and 606, respectively. Theintermediate section 110 includes the opening 118 between the interior120 thereof and a trough 608 in the distal section 606 configured forreceiving the gear engagement assembly 144. The drive shaft cartridge604 includes a distal section 610 having an opening in a distal end 612thereof configured for passage therethrough of the drive shaft 142extending distally from the gear engagement assembly 144.

The handle 602 and the drive shaft cartridge 604 are removably connectedby first inserting the gear engagement assembly 144 through the opening118 into the interior 120 of the intermediate section 110. The gearengagement assembly 144 and the prime mover carriage 124 within theinterior 120 are removably coupled as described elsewhere with referenceto device 100. Then the handle 602 and the drive shaft cartridge 604 areremovably connected by juxtaposing the distal sections 606 and 610, anddisplacing the handle 602 and the drive shaft cartridge 604 towards oneanother.

In FIG. 6, the device 600 is illustrated having a first and a secondconnector, each having complementary first and section sectionsconfigured for removably connecting the handle 602 and the drive shaftcartridge 604. The first section of the first connector is shown asopposing hooks 614 and 616 integrally formed with respective opposingside walls and/or edges 618 and 620 of the distal section 606. Thecomplementary second section of the first connector includes hookreceptors (not shown) for the hooks 614 and 616 are integrally formedwith the opposing side walls and/or edges, e.g., wall/edge 622, of thedistal section 610. The hook receptors are configured for removablyreceiving the hooks 614 and 616. When the juxtaposed handle 602 and thedrive shaft cartridge 604 are displaced towards one another, the hooks614 and 616 are slidably and removably received in the hook receptors inthe distal section 610.

The second connector for removably connecting the handle 602 and thedrive shaft cartridge is a tabbed connector. The first section of thetabbed connector is shown as a tab 624 integrally formed with the distalsection 610 at a proximal end (or edge or wall) 626 thereof. Thecomplementary second section of the second connector is shown as a tabreceptor 628 integrally formed with the handle 602 at a distal end (oredge or wall) 630 of the intermediate section 110. The tab receptor 628is configured for slidably and removably receiving at least a portion ofthe tab 624. When the juxtaposed handle 602 and the drive shaftcartridge 604 are displaced towards one another, the tab 624 is slidablyand removably received by the tab receptor on the handle 602.

In some embodiments, the device 600 includes one or more alignmentelements having complementary first and second sections configured foraligning the distal sections 606 and 610 with one another in preparationfor or while removably connecting the handle 602 and the drive shaftcartridge 604 with one another. In certain embodiments, the one or morealignment elements are configured as tongue-and-groove elementsintegrally formed with side edges of the distal sections 606 and 610.

In some embodiments, the first and the second connectors operateconcurrently for removably connecting the handle 602 and the drive shaftcartridge 604. In certain embodiments, one of the first and the secondconnectors operates before the other. Additionally or in thealternative, one or both of the first and the second connectors may beconfigured as a first and a second alignment element for aligning thedistal sections 606 and 610, respectively, of the handle 602 and thedrive shaft cartridge 604.

For replacing or exchanging an installed drive shaft cartridge 604 withanother, the first and the second connector are operated to disengagetheir respective first and second sections, and the handle 602 and thedrive shaft cartridge 604 are displaced away from one another The gearengagement assembly 144 is then removed from the intermediate section110 through the opening 118. Some embodiments of the device 600 includea support 632 for holding the gear engagement assembly 144 proximate theopening 118 and aligning them prior to inserting the gear engagementassembly 144 into the interior 120 of the intermediate section 110through the opening 118. The support 632 can also be used for holdingthe gear engagement assembly 144 when it is removed from the interior120 of the intermediate section 110 through the opening 118. The support632 may also be configured for protecting at least a portion of the gearengagement assembly 144, including the drive shaft gear 148, while thehandle 602 and the drive shaft cartridge 604 are not connected.

While specific configurations have been described with reference to thefirst and the second connector and with reference to the one or morealignment elements, additional and/or alternative embodiments willbecome apparent to those having ordinary skill in the art. All suchadditional and/or alternative embodiments configured for providing thesame or substantially similar functionalities are considered as beingwithin the metes and bounds of the instant disclosure.

FIG. 7A is a perspective view of an embodiment of a rotationalatherectomy device 700 in a dis-assembled state. Elements and componentsof the device 700 that are substantially similar or the same as those inother embodiments of the device are identified with the same referencenumerals. Device 700 includes a handle 702 and an exchangeable driveshaft cartridge 704, wherein the handle 702 and the drive shaftcartridge 704 include one or more connectors configured for removablyconnecting the handle 702 and the drive shaft cartridge 704 to oneanother. The handle 702 includes the proximal section 106, a distalsection 706, and an elongated hollow intermediate section 708 extendingbetween the proximal and distal sections 106 and 706, respectively. Theintermediate section 708 includes a door 710 operable for accessing theinterior 120 thereof, and the opening 118 between the interior 120 andthe trough or channel 112 in the distal section 706. The drive shaftcartridge 704 includes the drive shaft 142 extending distally from thegear engagement assembly 144, and a distal section 712 having an openingat a distal end thereof through which the drive shaft 142 extends.Although not shown, and as with other embodiments of the device, thedevice 700 includes one or more connectors each having complementaryfirst and second section configured for removably connecting the distalsections 706 and 712 to one another. As with other embodiments of thedevice, the device 700 can include one or more alignment elements.

FIG. 7B is a detailed side view illustrating a pivoting connector 714configured for removably and pivotably coupling the prime mover carriage124 and the gear engagement assembly 144 to one another. The pivotingconnector 714 is further configured for aligning and meshing the primemover gear 128 and the drive shaft gear 148. The pivoting connector 714includes a pivot point or axis 716 and complementary first and secondsections integrally formed with the prime mover carriage 124 and thegear engagement assembly 144. The prime mover carriage 124 and the gearengagement assembly 144 are pivotably and removably connected at theirrespective first and second sections.

For “loading” the device 700, the interior 120 of the intermediatesection 708 is exposed by opening the door 710. The prime mover carriage124 and the gear engagement assembly 144 are pivotably and removablycoupled at the pivot point or axis 716 of the pivoting connector 714such that the prime mover gear 138 and the drive shaft gear 148 arealigned. Next, the distal sections 706 and 712 are juxtaposed bydisplacing them towards each other by rotating the handle 702 and thedrive shaft cartridge 704 about the pivot point or axis 716. The primemover gear 138 and the drive shaft gear 148 will be meshed when thedistal sections 706 and 712 are removably connected. Thereafter, thedoor 710 is closed, and the device 700 is ready for use. For “unloading”the device 700, the process for “loading” the device 700 is performed inreverse.

FIG. 8 is a side view of another embodiment of a rotational atherectomydevice 800 in a partially dis-assembled state. Elements and componentsof the device 800 that are substantially similar or the same as those inother embodiments of the device are identified with the same referencenumerals. Device 800 includes a handle 802 and an exchangeable driveshaft cartridge 804 configured for being removably connected. In someembodiments, the device 800 includes a first connector and a secondconnector, each having complementary first and second sectionsconfigured for removably connecting the handle 802 and the drive shaftcartridge 804 to each other.

In FIG. 8, the first connector is illustrated as a pivoting connectorhaving a first section integrally formed with a distal section 806 ofthe handle 802, and a second section integrally formed with anintermediate section 808 of the drive shaft cartridge 804. The secondconnector is illustrated as a tabbed connector wherein the first sectionis a slidable tab 810 integrally formed with an elongated hollowintermediate section 812 of the handle 802, and wherein the secondsection is a tab receptor (not shown) integrally formed with a proximalsection 814 of the drive shaft cartridge 804. The illustrated locationsof the first and the second connectors are primarily for the purpose ofdescribing the device 800. Of course, the complementary first and secondsections, respectively, of the first and the second connector can beformed elsewhere on the handle 802 and the drive shaft cartridge 804subject to providing the required functionality, including ensuring thatthe prime mover gear 128 and the drive shaft gear 148 will be alignedfor proper meshing when the handle 802 and the drive shaft cartridge 804are removably connected.

For “loading” the device 800, the first and second sections of the firstconnector are used for pivotably and removably connecting the distalsection 806 of the handle 802 and the intermediate section 808 of thedrive shaft cartridge 804 with one another. Next, the intermediatesection 812 of the handle 802 and the proximal section 814 of the driveshaft cartridge 804 are juxtaposed by displacing them towards each otherby rotating the handle 802 and the drive shaft cartridge 804 about apivot point or axis 816 of the pivotable first connector. Then, theprime mover carriage 124 and the gear engagement assembly 144 arepositioned such that the prime mover gear 128 and the drive shaft gear148 are aligned. Thereafter, the first and second sections of the secondconnector will operate, automatically or manually, to removably connectthe intermediate section 812 and the proximal section 814 to oneanother. And, the prime mover gear 128 and the drive shaft gear 148 willbe meshed. The second connector can also be operated to dis-connect theintermediate section 812 of the handle 802 and the proximal section 814of the drive shaft cartridge 804 from one another.

Some embodiments of the device 800 include a third connector havingcomplementary first and second sections for removably connecting thehandle 802 and the drive shaft cartridge 804 to one another at locationsin addition to or alternatively to the first and the second connectors.FIG. 8 illustrates a third connector for an additional removableconnection between the handle 802 and the drive shaft cartridge 804. Insome embodiments, the third connector is configured as a tabbedconnector having a first section 818 integrally formed with theintermediate section 812 of the handle 802, and the second sectionintegrally formed with the intermediate section 808 of the drive shaftcartridge 804. The third connector can be configured for operatingautomatically or by a user of the device 800 after or concurrently withthe second connector.

For “unloading” the device 800, the process for “loading” the device 800is performed in reverse. As with other embodiments of the device, thedevice 800 can include one or more alignment elements.

FIG. 9 is a side view of yet another embodiment of a rotationalatherectomy device 900 in a partially dis-assembled state Elements andcomponents of the device 900 that are substantially similar or the sameas those in other embodiments of the device are identified with the samereference numerals. With reference to FIGS. 8 and 9, it should beapparent that the respective illustrated devices 800 and 900 aresubstantially similar to each other. One difference between the devices800 and 900 is that locations of the first and the second connectors areswapped. Specifically, the first connector, configured as a pivotingconnector, pivotably and removably connects an elongated hollowintermediate section 902 of a handle 904 to a proximal section 906 of anexchangeable drive shaft cartridge 908. And, the second connector,configured as a tabbed connector, removably connects a distal section910 of the handle 904 and an intermediate section 912 of the drive shaftcartridge 908 to one another.

For “loading” the device 900, the first and second sections of the firstconnector are used for pivotably and removably connecting theintermediate section 902 of the handle 904 and the proximal section 906of the drive shaft cartridge 908 to one another. Next, the prime movercarriage 124 and the gear engagement assembly 144 are position such thatthe prime mover gear 128 and the drive shaft gear 148 are aligned. Then,the distal section 910 of the handle 904 and the intermediate section912 of the drive shaft cartridge 908 are juxtaposed by displacing themtowards each other by rotating the handle 904 and the drive shaftcartridge 908 about a pivot point or axis 914 of the pivotable firstconnector. Thereafter, the first and second sections of the secondconnector will operate, automatically or manually, to removably connectthe distal section 910 of the handle 904 and the intermediate section912 of the drive shaft cartridge 904 to one another. And, the primemover gear 128 and the drive shaft gear 148 will be meshed. The secondconnector can also be operated to dis-connect the distal section 910 ofthe handle 904 and the intermediate section 912 of the drive shaftcartridge 904 from one another. As with device 800, the device 900 canalso include a substantially similar third connector.

For “unloading” the device 900, the process for “loading” the device 900is performed in reverse. As with other embodiments of the device, thedevice 900 can include one or more alignment elements.

FIG. 10 illustrates an embodiment of a system 1000 configured foridentifying, monitoring, and controlling the operation of a plurality ofdevices and components used for performing atherectomy. In someembodiments, at least a portion of the system 1000 is configured forwireless or contact-less communications 1002 between two or more devicesand components used for performing atherectomy. In certain non-limitingexemplary embodiments, the mode of communications 1002 includes one ormore of radio frequency (RF) and infra-red (IR), among others. In someembodiments, the system 1000 includes one or more wireless orcontact-less identification tags, e.g., NFC/RFID tag, 1004 disposed onone or more devices and components of a rotational or orbitalatherectomy device. In a non-limiting exemplary embodiments, the one ormore identification tags 1004 provide a contact-less means foridentifying different shafts/crowns or accessories 1006 attached to arotational or orbital atherectomy device (OAD) 1008. The identifyinginformation would allow the main control board 1010 to vary itsoperational parameters as needed to properly control or interface withthe attachment 1006. In certain embodiments, the one or moreidentification tags can be disposed on one or more devices and/orcomponents used with the OAD.

In a non-limiting exemplary embodiment, the one or more identificationtags 1004 can be disposed on a removable portion of the OAD and, whenattached to the main body of the device, an NFC/RFID reader 1012 wouldidentify the attachment 1006 and obtain its operational parameters. Thereader 1012 then communicates 1014 this information to the control board1010. In some embodiments, the one or more identification tags 1004 areconfigured for storing data that can be used for analysis. In certainembodiments, device and/or component usage statistics such as, total runtime, time spent at various speeds, etc., can be used for generating asnapshot of the atherectomy procedure.

In some embodiments, the one or more identification tags 1004 can beused as a safety mechanism such as not allowing the OAD to operate if arequired attachment is not connected. In certain embodiments, the one ormore identification tags can be used for inventory management andtracking data 1016 that can be collected in the field and transmitted toa remote center, e.g., remote servers, 1018. In a non-limiting exemplaryembodiment, WiFi and/or cellular networks can be used for thetransmission using a smartphone 1020 after collecting the data from thetag 1004.

In certain embodiments, the one or more identification tags areconfigured for harvesting energy for providing energy or power foroperating the one or more components and devices of the system 1000.Some non-limiting exemplary embodiments for harvesting energy includeharvesting RF energy.

The descriptions of the embodiments and their applications as set forthherein should be construed as illustrative, and are not intended tolimit the scope of the disclosure. Features of various embodiments maybe combined with other embodiments and/or features thereof within themetes and bounds of the disclosure. Upon study of this disclosure,variations and modifications of the embodiments disclosed herein arepossible, and practical alternatives to and equivalents of the variouselements of the embodiments will be understood by and become apparent tothose of ordinary skill in the art. Such variations and modifications ofthe embodiments disclosed herein may be made without departing from thescope and spirit of the invention. Therefore, all alternatives,variations, modifications, etc., as may become to one of ordinary skillin the art are considered as being within the metes and bounds of theinstant disclosure.

What is claimed is:
 1. A device, comprising: a handle, comprising: aproximal section; a distal section comprising a channel extendingproximally from an opening in a distal end of the handle; and anelongated hollow intermediate section between the proximal section andthe distal section, the intermediate section comprising: an openingbetween an interior thereof and the channel in the distal section; and aslot; a prime mover carriage comprising a prime mover, the prime movercarriage disposed within the interior of the intermediate section; aprime mover gear fixedly attached to a shaft of the prime mover; acontrol knob having at least a portion thereof extending through theslot and operationally coupled to the prime mover carriage such that alongitudinal displacement of the control knob induces a longitudinaldisplacement of the prime mover carriage, the control knob comprising:an unlocked state for permitting the longitudinal displacement of thecontrol knob; and a locked state for inhibiting the longitudinaldisplacement of the control knob; an exchangeable drive shaft cartridge,comprising: a proximal section and a distal section; a drive shaftcomprising a proximal end and a distal end, the drive shaft extendingthrough an opening in a distal end of the drive shaft cartridge; a gearengagement assembly, comprising a drive shaft gear fixedly attached tothe proximal end of the drive shaft; a first connector for removably andpivotally connecting the handle and the drive shaft cartridge to oneanother; and a second connector for removably connecting the handle andthe drive shaft cartridge to one another.
 2. The device of claim 1,wherein: the first connector is a pivoting connector comprisingcomplementary first and second sections, wherein: the first section isintegrally formed with the distal section of the handle; and the secondsection is integrally formed with the drive shaft cartridge; and thesecond connector comprises complementary first and second sections,wherein: the first section is integrally formed with the handle; and thesecond section is integrally formed with the proximal section of thedrive shaft cartridge; wherein, removably connecting the handle and thedrive shaft cartridge using the second connector removably meshes theprime mover gear and the drive shaft gear, such that a rotationalmovement of one of the prime mover and the drive shaft induces arotational movement in the other.
 3. The device of claim 1, wherein: thefirst connector is a pivoting connector comprising complementary firstand second sections, wherein: the first section is integrally formedwith the handle; and the second section is integrally formed with theproximal section of the drive shaft cartridge; and the second connectorcomprises complementary first and second sections, wherein: the firstsection is integrally formed with the distal section of the handle; andthe second section is integrally formed with the drive shaft cartridge;wherein: at least the prime mover gear and the drive shaft gear arealigned with one another when the handle and the drive shaft cartridgeare removably and pivotally connected using the first connector; andremovably connecting the handle and the drive shaft cartridge using thesecond connector removably meshes the prime mover gear and the driveshaft gear, such that a rotational movement of one of the prime moverand the drive shaft induces a rotational movement in the other.
 4. Thedevice of claim 1, wherein the second connector is selected from thegroup consisting of snap-fit connectors, tongue and groove connectors,and tabbed connectors.
 5. The device of claim 1, wherein the interior ofthe intermediate section of the handle is configured for: longitudinaldisplacement of the prime mover carriage disposed therewithin;longitudinal displacement of the gear engagement assembly; andlongitudinal displacement of the drive shaft.
 6. The device of claim 1,wherein the longitudinal displacement of the prime mover carriageinduces a longitudinal displacement of the gear engagement assembly andof the drive shaft extending from the gear engagement assembly when thedistal section of the handle and the distal section of the drive shaftcartridge are removably connected.
 7. The device of claim 1, wherein atleast a portion of the drive shaft is telescoping.
 8. The device ofclaim 1, wherein the prime mover is selected from the group consistingof a turbine and an electric motor.
 9. The device of claim 1, comprisingone or more sensors for monitoring a rotational speed of at least one ofthe prime mover shaft and the drive shaft.
 10. The device of claim 1,comprising: a lumen having the drive shaft disposed therewithin; a fluidinfusion port in fluid communication with the lumen; and a fluidreservoir in fluid communication with the fluid infusion port; wherein,the fluid infusion port is configured for delivering fluid from thefluid reservoir to the lumen.
 11. The device of claim 1, wherein thedistal end of the drive shaft is configured for insertion into avasculature.
 12. The device of claim 11, comprising an abrasive elementproximate the distal end of the drive shaft.